Open-label, follow-on Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.

This study is ongoing, but not recruiting participants.

First Received: October 16, 2007 Last Updated: January 5, 2010 History of Changes

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00546351

Purpose

The primary objective of the trial is to assess the tolerability and safety of long-term lacosamide administration in subjects with painful distal diabetic neuropathy.

Condition	Intervention	Phase
Painful Diabetic Neuropathy	Drug: Lacosamide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Multi-center, Open-label, follow-on Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy Including a Double-blind, Randomized Time Point Withdrawal Subtrial.

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Nerve Problems

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

To assess the tolerability and safety of long-term lacosamide administration in subjects with painful distal diabetic neuropathy. Assessment of adverse events, changes in laboratory parameters, ECGs, and physical examinations. [ Time Frame: 5.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary objective is to evaluate the efficacy of long-term use of lacosamide in this indication. Efficacy will be determined by pain score ratings assessed in a patient's diary and with ratings at the clinic visits. [ Time Frame: 5.5 years ] [ Designated as safety issue: No ]

Enrollment:	614
Study Start Date:	May 2004
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Open label active treatment	Drug: Lacosamide Film-coated tablets; two times per day Lacosamide up to 600 mg/day; 5.5 years

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Completion of prior double-blind trial.

Exclusion Criteria:

Clinically relevant liver enzyme abnormalities
Cardiac abnormalities
Pregnant or nursing females.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546351

Show 77 Study Locations

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	SP746, EudraCT-No.:, 2004-000551-42
Study First Received:	October 16, 2007
Last Updated:	January 5, 2010
ClinicalTrials.gov Identifier:	NCT00546351 History of Changes
Health Authority:	Austria: Agency for Health and Food Safety; Belgium: Directorate general for the protection of Public health: Medicines; Bulgaria: Ministry of Health; Czech Republic: State Institute for Drug Control; Finland: Finnish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut; Hungary: National Institute of Pharmacy; Italy: Ministry of Health; Poland: Ministry of Health; Romania: National Medicines Agency; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Spain: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by UCB, Inc.:

Lacosamide

Additional relevant MeSH terms:

Signs and Symptoms
Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Nervous System Diseases

Diabetes Mellitus
Neurologic Manifestations
Endocrine System Diseases
Pain
Diabetes Complications

ClinicalTrials.gov processed this record on February 08, 2010